Z-2378-2018 Class II Terminated
FDA device recall Z-2378-2018 was initiated by Medline Industries, Inc. on Jan 12, 2018 and is designated Class II. Reason for recall: One of the cases of product might not have been sterilized. The recall status is terminated (terminated Jul 22, 2020). Affected quantity: 6/5-kit cases.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 18, 2018
- Initiation Date
- Jan 12, 2018
- Termination Date
- Jul 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6/5-kit cases
Product Description
BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
Reason for Recall
One of the cases of product might not have been sterilized.
Distribution Pattern
The product was distributed to UT.
Code Information
Lot 17YM5936, Exp. 04/30/2019
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2378-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026